An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants

• Sponsor: Janssen Korea, Ltd., Korea (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00760669
• Collaborator: (none)
• Enrollment: 1,061
• Duration (Months): 47

Study Details

Study Description

Brief Summary

The purpose of this observational study is to evaluate the safety and effectiveness of infliximab injection under actual conditions of use in participants, and to learn more about its adverse events.

Condition or Disease	Intervention/Treatment	Phase
Spondylitis, Ankylosing; Arthritis, Rheumatoid; Psoriasis; Arthritis, Psoriatic	Drug: Infliximab; observational study; Drug: Methotrexate; observational study

Detailed Description

This is an observational, prospective (study following participants forward in time) study to assess safety and efficacy of infliximab injection under post-marketing use and identify problems related to adverse events in participants with ankylosing spondylitis (chronic inflammatory condition affecting the axial joints), rheumatoid arthritis (chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures), psoriasis (scaly skin rash) and psoriatic arthritis (a type of inflammatory arthritis associated with psoriasis). Participants with rheumatoid arthritis will receive 6 doses of infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6 and will be observed for 30 weeks; and those with ankylosing spondylitis, psoriasis and psoriatic arthritis will also receive 6 doses of injection and will be observed for 24 to 30 weeks. Efficacy will be evaluated by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Erythrocyte Sedimentation Rate (ESR), C-reactive protein (CRP), Psoriasis Area and Severity Index (PASI), swollen joint counts and tender joint count. Participants' safety will be monitored throughout the study.

Study Design

• Study Type: Observational
• Actual Enrollment: 1061 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Patients
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Participants Receiving Infiximab Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving infliximab injection will be observed.

Drug: Infliximab; observational study; This is an observational study. Participants with RA, AS and PA receiving induction intravenous infusions (a fluid or a medicine delivered into a vein by way of a needle) of infliximab will be observed. Participants with RA will receive infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks. Participants with AS and PA will receive 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.; Other Names: Remicade Injection ; Drug: Methotrexate; observational study; Participants with RA will receive methotrexate based on physician's clinical judgement.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30 [Baseline and Week 30]

   The BASDAI is a validated self-assessment tool used to assess disease activity in participants with ankylosing spondylitis. It consists of 6 items measuring fatigue, spinal pain, joint pain, areas of localized tenderness, intensity of morning stiffness and duration of morning stiffness. First 5 items are scored on a 10 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm=none to 10 mm=severe; and sixth item is scored on VAS ranging from 0=0 hours to 10=2 or more hours. The total BASDAI score ranges from 0 (none) to 10 (very severe).To give each symptom equal weighting, the average of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score is divided by 5 to give a final BASDAI score. BASDAI total score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).

2. Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30 [Baseline and Week 30]

   The ESR is a laboratory test that provides a non-specific measure of inflammation. It assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm per hour. A higher rate indicated inflammation.

3. Change From Baseline in C-Reactive Protein (CRP) at Week 30 [Baseline and Week 30]

   The CRP is acute serum protein released from liver. It is associated with low hemoglobin or erythropoetic resistance. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is less than 1 milligram per deciliter (mg/dl). A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.

4. Change From Baseline in Number of Swollen Joints at Week 30 [Baseline and Week 30]

   Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 2, where 0=no swelling, 1=swelling, but bony landmarks seen and 2=swelling but bone marks not seen.

5. Change From Baseline in Number of Tender Joints at Week 30 [Baseline and Week 30]

   Number of tender joints was determined by examination of 28 joints and identifying when tenderness was present. The number of tender joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 3, where 0=no pain, 1=mild, 2= moderate and 3=severe.

6. Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30 [Baseline and Week 30]

   The PASI is combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. Body is divided into 4 sections (head, arms, trunk and legs); each area is scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, thickness, and scaling; scale: 0 (none) to 4 (severe). Final PASI=sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

7. Overall Efficacy Assessment [Baseline up to Week 30]

   The level of improvement in symptom before and after the administration of the drug was assessed as per Investigator's discretion and the overall efficacy was assessed based on this result. The level of improvement in disease was assessed in three steps: improved, unchanged and aggravated as per Investigator's discretion.

8. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to Week 30]

   An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

9. Number of Participants With Unexpected Adverse Events [Baseline up to Week 30]

   Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.

10. Number of Participants With Adverse Drug Reactions [Baseline up to Week 30]

    Adverse drug reactions are defined as adverse events for which the Investigator had not described the causal relationship to trial medication as "not related".

11. Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction [Baseline up to Week 30]

    An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Drug abuse is defined as the use of the study drug for a non-therapeutic effect, misuse was defined as use of the study medication in a way that was not prescribed and drug interaction was defined as a chemical or physiological reaction that can occur when 2 different drugs are taken together.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants with ankylosing spondylitis who did not show adequate response to general treatments and with increased serological indices related to severe axial symptoms and inflammation

• Participants with rheumatoid arthritis who show insufficient response to disease modifying antirheumatic drug (DMARD) including methotrexate

• Participants with serious, active and progressive disease not previously treated with methotrexate or other DMARD

• Participant with moderate to serious plaque psoriasis who are unresponsive, contra indicant or intolerable to the systemic therapy including cyclosporine, methotrexate or Psoralen Ultra-Violet A (PUVA)

• Participant with active, progressive, psoriatic arthritis who have shown insufficient response to DMARD treatment

Exclusion Criteria:

None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Janssen Korea, Ltd., Korea

Investigators

• Study Director: Janssen Korea, Ltd., Korea Clinical Trial, Janssen Korea, Ltd., Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen Korea, Ltd., Korea
• ClinicalTrials.gov Identifier: NCT00760669
• Other Study ID Numbers: CR100768; REMICADEAKS4004
• First Posted: Sep 26, 2008
• Last Update Posted: Oct 29, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Janssen Korea, Ltd., Korea: Spondylitis, Ankylosing; Arthritis, Rheumatoid; Psoriasis; Arthritis, Psoriatic; Infliximab; Remicade
• Additional relevant MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Spondylarthritis; Arthritis, Psoriatic; Spondylitis, Ankylosing; Psoriasis; Methotrexate; Infliximab

Study Results

Participant Flow

Arm/Group Title	Participants Receiving Infliximab
Arm/Group Description	Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
Period Title: Overall Study
STARTED	1061
COMPLETED	1031
NOT COMPLETED	30

Baseline Characteristics

Arm/Group Title	Participants Receiving Infliximab
Arm/Group Description	Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
Overall Participants	1055
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.32 (13.84)
Sex: Female, Male (Count of Participants)
Female	363 34.4%
Male	692 65.6%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30
Description	The BASDAI is a validated self-assessment tool used to assess disease activity in participants with ankylosing spondylitis. It consists of 6 items measuring fatigue, spinal pain, joint pain, areas of localized tenderness, intensity of morning stiffness and duration of morning stiffness. First 5 items are scored on a 10 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm=none to 10 mm=severe; and sixth item is scored on VAS ranging from 0=0 hours to 10=2 or more hours. The total BASDAI score ranges from 0 (none) to 10 (very severe).To give each symptom equal weighting, the average of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score is divided by 5 to give a final BASDAI score. BASDAI total score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).
Time Frame	Baseline and Week 30

Outcome Measure Data

Analysis Population Description

The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with ankylosing spondylitis and were evaluated for this outcome measure.

Arm/Group Title	Participants Receiving Infliximab
Arm/Group Description	Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
Measure Participants	705
Baseline	7.52 (6.68)
Change at Week 30	-5.23 (4.51)

2. Primary Outcome

Title	Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30
Description	The ESR is a laboratory test that provides a non-specific measure of inflammation. It assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm per hour. A higher rate indicated inflammation.
Time Frame	Baseline and Week 30

Outcome Measure Data

Analysis Population Description

The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this outcome measure.

Arm/Group Title	Participants Receiving Infliximab
Arm/Group Description	Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
Measure Participants	248
Baseline	60.75 (29.84)
Change at Week 30	-21.80 (29.88)

3. Primary Outcome

Title	Change From Baseline in C-Reactive Protein (CRP) at Week 30
Description	The CRP is acute serum protein released from liver. It is associated with low hemoglobin or erythropoetic resistance. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is less than 1 milligram per deciliter (mg/dl). A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.
Time Frame	Baseline and Week 30

Outcome Measure Data

Analysis Population Description

The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.

Arm/Group Title	Participants Receiving Infliximab
Arm/Group Description	Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
Measure Participants	262
Baseline	7.94 (14.04)
Change at Week 30	-4.81 (11.23)

4. Primary Outcome

Title	Change From Baseline in Number of Swollen Joints at Week 30
Description	Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 2, where 0=no swelling, 1=swelling, but bony landmarks seen and 2=swelling but bone marks not seen.
Time Frame	Baseline and Week 30

Outcome Measure Data

Analysis Population Description

The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.

Arm/Group Title	Participants Receiving Infliximab
Arm/Group Description	Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
Measure Participants	239
Baseline	9.75 (6.53)
Change at Week 30	-5.46 (6.02)

5. Primary Outcome

Title	Change From Baseline in Number of Tender Joints at Week 30
Description	Number of tender joints was determined by examination of 28 joints and identifying when tenderness was present. The number of tender joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 3, where 0=no pain, 1=mild, 2= moderate and 3=severe.
Time Frame	Baseline and Week 30

Outcome Measure Data

Analysis Population Description

The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.

Arm/Group Title	Participants Receiving Infliximab
Arm/Group Description	Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
Measure Participants	240
Baseline	13.31 (7.75)
Change at Week 30	-7.35 (7.42)

6. Primary Outcome

Title	Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30
Description	The PASI is combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. Body is divided into 4 sections (head, arms, trunk and legs); each area is scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, thickness, and scaling; scale: 0 (none) to 4 (severe). Final PASI=sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Time Frame	Baseline and Week 30

Outcome Measure Data

Analysis Population Description

Data was not evaluated as only 1 participant with psoriatic arthritis was enrolled in this surveillance and no PASI evaluation was done for it.

Arm/Group Title	Participants Receiving Infliximab
Arm/Group Description	Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
Measure Participants	0

7. Primary Outcome

Title	Overall Efficacy Assessment
Description	The level of improvement in symptom before and after the administration of the drug was assessed as per Investigator's discretion and the overall efficacy was assessed based on this result. The level of improvement in disease was assessed in three steps: improved, unchanged and aggravated as per Investigator's discretion.
Time Frame	Baseline up to Week 30

Outcome Measure Data

Analysis Population Description

The efficacy assessment analysis set included all participants who were assessed for efficacy assessment.

Arm/Group Title	Participants Receiving Infliximab
Arm/Group Description	Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
Measure Participants	1031
Improved	948 89.9%
Unchanged	59 5.6%
Aggravated	24 2.3%

8. Primary Outcome

Title	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Baseline up to Week 30

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study medication.

Arm/Group Title	Participants Receiving Infliximab
Arm/Group Description	Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
Measure Participants	1055
AEs	106 (7.75) 10%
SAEs	12 (7.42) 1.1%

9. Primary Outcome

Title	Number of Participants With Unexpected Adverse Events
Description	Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.
Time Frame	Baseline up to Week 30

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study medication.

Arm/Group Title	Participants Receiving Infliximab
Arm/Group Description	Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
Measure Participants	1055
Number [Participants]	28 (7.42) 2.7%

10. Primary Outcome

Title	Number of Participants With Adverse Drug Reactions
Description	Adverse drug reactions are defined as adverse events for which the Investigator had not described the causal relationship to trial medication as "not related".
Time Frame	Baseline up to Week 30

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study medication.

Arm/Group Title	Participants Receiving Infliximab
Arm/Group Description	Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
Measure Participants	1055
Number [Participants]	59 (7.75) 5.6%

11. Primary Outcome

Title	Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction
Description	An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Drug abuse is defined as the use of the study drug for a non-therapeutic effect, misuse was defined as use of the study medication in a way that was not prescribed and drug interaction was defined as a chemical or physiological reaction that can occur when 2 different drugs are taken together.
Time Frame	Baseline up to Week 30

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study medication.

Arm/Group Title	Participants Receiving Infliximab
Arm/Group Description	Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
Measure Participants	1055
Number [Participants]	48 4.5%

Adverse Events

Time Frame	Baseline up to 30 weeks
Arm/Group Title	Participants Receiving Infliximab
Arm/Group Description	Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
All Cause Mortality
	Participants Receiving Infliximab
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Participants Receiving Infliximab
	Affected / at Risk (%)	# Events
Total	12/1055 (1.1%)
Cardiac disorders
Acute myocardial infarction	1/1055 (0.1%)
Eye disorders
Glaucoma	1/1055 (0.1%)
Infections and infestations
Cellulitis	2/1055 (0.2%)
Pulmonary tuberculosis	2/1055 (0.2%)
Disseminated tuberculosis	1/1055 (0.1%)
Gastroenteritis	1/1055 (0.1%)
Pneumonia	1/1055 (0.1%)
Injury, poisoning and procedural complications
Extradural haematoma	1/1055 (0.1%)
Spinal fracture	1/1055 (0.1%)
Spinal shock	1/1055 (0.1%)
Tendon rupture	1/1055 (0.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/1055 (0.1%)
Back pain	1/1055 (0.1%)
Neck pain	1/1055 (0.1%)
Other (Not Including Serious) Adverse Events
	Participants Receiving Infliximab
	Affected / at Risk (%)	# Events
Total	95/1055 (9%)
Blood and lymphatic system disorders
Anaemia	2/1055 (0.2%)
Cardiac disorders
Palpitations	1/1055 (0.1%)
Eye disorders
Ocular hyperaemia	1/1055 (0.1%)
Gastrointestinal disorders
Dyspepsia	4/1055 (0.4%)
Abdominal pain	3/1055 (0.3%)
Epigastric discomfort	3/1055 (0.3%)
Nausea	3/1055 (0.3%)
Vomiting	3/1055 (0.3%)
Abdominal discomfort	2/1055 (0.2%)
Abdominal pain upper	1/1055 (0.1%)
Constipation	1/1055 (0.1%)
Diarrhoea	1/1055 (0.1%)
Gastric ulcer	1/1055 (0.1%)
Gingivitis	1/1055 (0.1%)
Haematochezia	1/1055 (0.1%)
Mouth ulceration	1/1055 (0.1%)
General disorders
Chills	4/1055 (0.4%)
Chest discomfort	3/1055 (0.3%)
Asthenia	1/1055 (0.1%)
Chest pain	1/1055 (0.1%)
Face oedema	1/1055 (0.1%)
Fatigue	1/1055 (0.1%)
Oedema peripheral	1/1055 (0.1%)
Pyrexia	1/1055 (0.1%)
Hepatobiliary disorders
Hepatitis	1/1055 (0.1%)
Hepatotoxicity	1/1055 (0.1%)
Immune system disorders
Anaphylactic reaction	1/1055 (0.1%)
Infections and infestations
Nasopharyngitis	6/1055 (0.6%)
Upper respiratory tract infection	6/1055 (0.6%)
Folliculitis	2/1055 (0.2%)
Arthritis bacterial	1/1055 (0.1%)
Bronchitis	1/1055 (0.1%)
Cellulitis	1/1055 (0.1%)
Chronic tonsillitis	1/1055 (0.1%)
Latent tuberculosis	1/1055 (0.1%)
Oral herpes	1/1055 (0.1%)
Pelvic abscess	1/1055 (0.1%)
Pharyngotonsillitis	1/1055 (0.1%)
Rhinitis	1/1055 (0.1%)
Tinea cruris	1/1055 (0.1%)
Injury, poisoning and procedural complications
Contusion	2/1055 (0.2%)
Investigations
Hepatic enzyme increased	12/1055 (1.1%)
Blood pressure increased	1/1055 (0.1%)
Hepatic enzyme abnormal	1/1055 (0.1%)
LE cells present	1/1055 (0.1%)
Metabolism and nutrition disorders
Decreased appetite	2/1055 (0.2%)
Hypercholesterolaemia	1/1055 (0.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/1055 (0.3%)
Back pain	2/1055 (0.2%)
Bursitis	1/1055 (0.1%)
Myalgia	1/1055 (0.1%)
Nervous system disorders
Dizziness	2/1055 (0.2%)
Headache	2/1055 (0.2%)
Paraesthesia	2/1055 (0.2%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	1/1055 (0.1%)
Renal and urinary disorders
Haematuria	1/1055 (0.1%)
Proteinuria	1/1055 (0.1%)
Reproductive system and breast disorders
Amenorrhoea	1/1055 (0.1%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	4/1055 (0.4%)
Cough	2/1055 (0.2%)
Oropharyngeal pain	1/1055 (0.1%)
Productive cough	1/1055 (0.1%)
Skin and subcutaneous tissue disorders
Urticaria	7/1055 (0.7%)
Pruritus	4/1055 (0.4%)
Rash	4/1055 (0.4%)
Rash generalised	2/1055 (0.2%)
Acne	1/1055 (0.1%)
Alopecia	1/1055 (0.1%)
Dermatitis atopic	1/1055 (0.1%)
Erythema	1/1055 (0.1%)
Skin exfoliation	1/1055 (0.1%)
Social circumstances
Pregnancy of partner	1/1055 (0.1%)
Vascular disorders
Hypertension	3/1055 (0.3%)
Flushing	1/1055 (0.1%)
Hypotension	1/1055 (0.1%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Principal Investigator (PI) cannot provide any trial related information to external parties' without mutual agreement with the Sponsor. This is valid even after the contract is canceled.